Application 019992

Type: NDA
Sponsor: NOVARTIS

Related Records

Company: NOVARTIS

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CILOXAN	CIPROFLOXACIN HYDROCHLORIDE	SOLUTION/DROPS;OPHTHALMIC	EQ 0.3% BASE	Yes	Yes

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0065-0656	Ciloxan	ciprofloxacin hydrochloride	Alcon Laboratories, Inc.	NDA	Current
0065-0656	Ciloxan	ciprofloxacin hydrochloride	Alcon Laboratories, Inc.	NDA	Current
0065-0656	Ciloxan	ciprofloxacin hydrochloride	Alcon Laboratories, Inc.	NDA	Current
0065-0656	Ciloxan	ciprofloxacin hydrochloride	Alcon Laboratories, Inc.	NDA	Current
0065-0656	Ciloxan	ciprofloxacin hydrochloride	Alcon Laboratories, Inc.	NDA	Current
0065-0656	Ciloxan	ciprofloxacin hydrochloride	Alcon Laboratories, Inc.	NDA	Current
21695-259	Ciprofloxacin Hydrochloride	ciprofloxacin hydrochloride	Rebel Distributors Corp	NDA	Current
33261-910	Ciprofloxacin Hydrochloride	Ciprofloxacin Hydrochloride	Aidarex Pharmaceuticals LLC	NDA AUTHORIZED GENERIC	Current
45865-877	Ciprofloxacin Hydrochloride	Ciprofloxacin Hydrochloride	medsource pharmaceuticals	NDA AUTHORIZED GENERIC	Current
50090-1754	Ciprofloxacin Hydrochloride	Ciprofloxacin Hydrochloride	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50436-0656	Ciprofloxacin Hydrochloride	Ciprofloxacin Hydrochloride	Unit Dose Services	NDA AUTHORIZED GENERIC	Current
53002-9320	Ciprofloxacin Hydrochloride	Ciprofloxacin Hydrochloride	RPK Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
53002-9320	Ciprofloxacin Hydrochloride	Ciprofloxacin Hydrochloride	RPK Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
55700-636	Ciprofloxacin Hydrochloride	Ciprofloxacin Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	NDA AUTHORIZED GENERIC	Current
61314-656	Ciprofloxacin Hydrochloride	Ciprofloxacin Hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
61314-656	Ciprofloxacin Hydrochloride	Ciprofloxacin Hydrochloride	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
61314-656	Ciprofloxacin Hydrochloride	Ciprofloxacin Hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
61919-491	CIPROFLOXACIN	ciprofloxacin hydrochloride solution	DIRECT RX	NDA	Current
61919-491	CIPROFLOXACIN	ciprofloxacin hydrochloride solution	DIRECT RX	NDA	Current
61919-491	CIPROFLOXACIN	ciprofloxacin hydrochloride solution	DIRECT RX	NDA	Current
61919-491	CIPROFLOXACIN	ciprofloxacin hydrochloride solution	DIRECT RX	NDA	Current
63187-985	Ciprofloxacin Hydrochloride	Ciprofloxacin Hydrochloride	Proficient Rx LP	NDA AUTHORIZED GENERIC	Current
63187-985	Ciprofloxacin Hydrochloride	Ciprofloxacin Hydrochloride	Proficient Rx LP	NDA AUTHORIZED GENERIC	Current
63187-985	Ciprofloxacin Hydrochloride	Ciprofloxacin Hydrochloride	Proficient Rx LP	NDA AUTHORIZED GENERIC	Current
68071-3351	Ciprofloxacin Hydrochloride	Ciprofloxacin Hydrochloride	NuCare Pharmaceuticals,Inc.	NDA AUTHORIZED GENERIC	Current
68071-3351	Ciprofloxacin Hydrochloride	Ciprofloxacin Hydrochloride	NuCare Pharmaceuticals,Inc.	NDA AUTHORIZED GENERIC	Current
68071-4139	Ciprofloxacin Hydrochloride	Ciprofloxacin Hydrochloride	NuCare Pharmaceuticals,Inc.	NDA AUTHORIZED GENERIC	Current
68071-4139	Ciprofloxacin Hydrochloride	Ciprofloxacin Hydrochloride	NuCare Pharmaceuticals,Inc.	NDA AUTHORIZED GENERIC	Current
68071-4139	Ciprofloxacin Hydrochloride	Ciprofloxacin Hydrochloride	NuCare Pharmaceuticals,Inc.	NDA AUTHORIZED GENERIC	Current
68071-4235	Ciprofloxacin Hydrochloride	Ciprofloxacin Hydrochloride	NuCare Pharmaceuticals,Inc.	NDA AUTHORIZED GENERIC	Current
68071-4235	Ciprofloxacin Hydrochloride	Ciprofloxacin Hydrochloride	NuCare Pharmaceuticals,Inc.	NDA AUTHORIZED GENERIC	Current
68071-4235	Ciprofloxacin Hydrochloride	Ciprofloxacin Hydrochloride	NuCare Pharmaceuticals,Inc.	NDA AUTHORIZED GENERIC	Current
68788-7100	Ciprofloxacin Hydrochloride	Ciprofloxacin Hydrochloride	Preferred Preferred Phamraceuticals Inc. Inc.	NDA AUTHORIZED GENERIC	Current
68788-7100	Ciprofloxacin Hydrochloride	Ciprofloxacin Hydrochloride	Preferred Preferred Phamraceuticals Inc. Inc.	NDA AUTHORIZED GENERIC	Current
68788-7100	Ciprofloxacin Hydrochloride	Ciprofloxacin Hydrochloride	Preferred Preferred Phamraceuticals Inc. Inc.	NDA AUTHORIZED GENERIC	Current
68788-8198	Ciprofloxacin Hydrochloride	Ciprofloxacin Hydrochloride	Preferred Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
70518-1170	Ciprofloxacin Hydrochloride	Ciprofloxacin Hydrochloride	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-1170	Ciprofloxacin Hydrochloride	Ciprofloxacin Hydrochloride	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-1234	Ciloxan	ciprofloxacin hydrochloride	REMEDYREPACK INC.	NDA	Current
70518-1234	Ciloxan	ciprofloxacin hydrochloride	REMEDYREPACK INC.	NDA	Current
70518-1234	Ciloxan	ciprofloxacin hydrochloride	REMEDYREPACK INC.	NDA	Current
70518-1234	Ciloxan	ciprofloxacin hydrochloride	REMEDYREPACK INC.	NDA	Current
70518-1234	Ciloxan	ciprofloxacin hydrochloride	REMEDYREPACK INC.	NDA	Current

Documents

Document	Submission type	Date
47682	SUPPL	2017-03-24
47637	SUPPL	2017-03-22
12123	SUPPL	2006-02-08
1893	SUPPL	2006-02-08
34175	SUPPL	2004-08-25
1892	SUPPL	2004-08-25
62904	ORIG	1900-01-01